Chinese Firm Makes Gilead Drug in Virus Fight, Raising IP Fears

Chinese Firm Makes Gilead Drug in Virus Fight, Raising IP Fears

(Bloomberg) — A Chinese drugmaker said it has started mass-producing an experimental treatment from Gilead Sciences Inc. that has shown potential to fight the novel coronavirus, adding to concerns that the U.S. pharma company is losing patent control in China’s accelerating effort to fight the outbreak.

Suzhou-based BrightGene Bio-Medical Technology Co. said it has developed technology to synthesize the active pharmaceutical ingredients of Gilead’s remdesivir. A leading candidate to treat the virus that’s killed more than 1,000 people, the drug isn’t licensed or approved anywhere in the world. BrightGene rose 20% Wednesday in Shanghai.

China Wants to Patent Gilead’s Experimental Coronavirus Drug (3)

While BrightGene said it intends to license the drug from Gilead, its move to start manufacturing at this early stage is highly unusual and a potential challenge to the U.S. company’s intellectual property. Last week, Chinese researchers at the Wuhan Institute of Virology filed an application in China to patent the drug, which was developed for Ebola, to treat the new coronavirus.

The aggressive moves to make and assume control of Gilead’s drug could revive concerns about the protection of intellectual property rights in China, long an area of concern for U.S. and European pharma companies, tech giants and others. The country has been making strides in the area as it nurtures a domestic industry based on innovative, patented drugs as companies develop their businesses in China.

China has a difficult balance to strike, as it tries to speed development of one of the most promising potential treatments for an illness that has infected almost 45,000 people without undermining those commitments.

Compulsory License

Despite the steps by BrightGene and Wuhan researchers, the central government has so far stopped short of seeking a “compulsory license,” which lets nations override drug patents in national emergencies. The hesitation to invoke that clause may be part of its continued efforts to demonstrate greater respect for companies’ rights.

“In general, production constitutes a patent infringement, but there’s an exception if the production is intended only for regulatory approval and not for sale in the market,” said Wang Yanyu, a Beijing-based partner specializing in intellectual property at AllBright Law Offices.

Gilead said it’s aware of BrightGene’s announcement and that it remains “focused on rapidly determining the potential for remdesivir to treat COVID-19,” the name given by the World Health Organization to the new syndrome. The company has said that any discussion of licensing the investigational drug is “premature.”

Because of its experience with drugs like remdesivir, BrightGene said, it’s been able to get ready for production quickly.

Large areas of China have been locked down by the coronavirus epidemic, while other countries are barring entry to some travelers. Gilead’s drug is seen as a potential breakthrough in the fight against the disease since it showed signs of helping patients in the U.S.

761 Patients

Chinese researchers are now testing the drug on 761 patients in clinical trials in Wuhan.

BrightGene said that before selling the drug, it will have to license it from Gilead, conduct clinical trials and obtain approval. Its technology to make remdesivir may not be of much value if the drug fails to produce results from clinical trials, or if the epidemic comes under control soon, it said.

Last week, Gilead said it has patented remdesivir in China, including filing applications for use on coronaviruses. The company also said that it is working with Chinese, U.S. and World Health Organization officials to rapidly determine whether the drug can be used to treat the virus.

–With assistance from John Lauerman.

To contact Bloomberg News staff for this story: Dong Lyu in Beijing at dlyu3@bloomberg.net

To contact the editors responsible for this story: Rachel Chang at wchang98@bloomberg.net, Eric Pfanner, Thomas Mulier

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